BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3880247 · Received April 8, 2014

    Report

    Report Number
    2936999-2014-00327
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 10, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED. IF A SAMPLE IS MADE AVAILABLE, A SUMMARY OF THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. MANUFACTURING CONTROLS ARE IN PLACE TO DETECT CUFF RELATED DEFECTS AND TO REDUCE THE POTENTIAL FOR OCCURRENCE DURING THE MANUFACTURING PROCESS. INFORMATION HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    ONE SAMPLE OF A TAPERGUARD WITH STYLET ENDOTRACHEAL TUBE PART NUMBER 18780S WAS RECEIVED FOR EVALUATION; LOT NUMBER PROVIDED BY CTS IS 13F0745JZX. AN INFLATION/DEFLATION TEST WAS PERFORMED, USING A SYRINGE, 25CC OF AIR WAS APPLIED TO THE CUFF AND IT WAS OBSERVED THAT AFTER 2 MINUTES THE CUFF DEFLATED. A VISUAL INSPECTION WAS PERFORMED AND IT WAS OBSERVED THE CUFF PRESENTED A SMALL CUT THAT LEAKED THE AIR. THE FAILURE MODE CUT IN CUFF WAS CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATES: PRIOR TO USE, A DOCTOR INSPECTED AND FOUND A TORN CUFF. NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211802 MALLINCKRODT TAPERGUARD TRACHEAL TUBE BTR COVIDIEN 13F0745JZX

    Patients

    Seq Age Sex Outcome Treatment
    1